Senior Analytical Specialist, iPSC

United Therapeutics • Silver Spring, MD

6d • Onsite

About The Position

The Senior Analytical Specialist performs analytical testing and supports quality activities for induced pluripotent stem cell (iPSC) banks. Working collaboratively across Manufacturing, Quality Assurance, Quality Control, and external partners, the role helps maintain assay performance, support product release, investigate laboratory deviations, and ensure adherence to GMP, regulatory, and company quality standards.

The position performs in-process and release testing, authors and reviews testing and validation documentation, and supports technology transfers, method qualification, validation, and equipment qualification. It also coordinates testing with external contract laboratories, maintains laboratory equipment and supplies, conducts investigations and CAPA activities, communicates testing status, trains manufacturing operators on sample preparation and basic equipment handling, and presents data in weekly meetings. The role is 100% onsite in Silver Spring, Maryland.

Requirements

• Bachelor’s degree in biology, molecular biology, immunology, or a related field.
• At least 5 years of relevant analytical-testing experience with a bachelor’s degree, or at least 3 years with a master’s degree.
• Proficiency performing lot-release assays and cell-characterization assays, including flow cytometry, qPCR, STR, endotoxin, and ELISA.
• Ability to independently troubleshoot assays.
• Experience with Good Documentation Practices (GDP) record keeping, preferably in a cGMP environment.
• Strong written and verbal communication skills, including the ability to interact cross-functionally and with management and clearly summarize testing status and quality issues.
• Detail-oriented, organized, and self-motivated, with the ability to prioritize work in a dynamic environment and work independently as well as in a multifunctional team.
• Excellent interpersonal skills and the ability to communicate and collaborate effectively across functions.

Nice To Haves

• Master’s degree in biology, molecular biology, immunology, or a related field.
• At least 2 years of experience in a GMP pharmaceutical laboratory.
• Knowledge of cGMP requirements and QC laboratory practices.
• Experience with method transfers, assay qualification, and validation.
• Experience performing equipment qualification (IQ/OQ/PQ).
• Familiarity with OOS/deviation investigation, including root-cause analysis (RCA) and CAPA execution in QC assays.
• Knowledge and understanding of sterility, mycoplasma, and NGS assays.

Responsibilities

• Independently perform in-process and release testing of iPSC banks, including flow cytometry, qPCR, STR, endotoxin, and ELISA.
• Author and/or review protocols, summary reports, and SOPs for testing, validation, method transfers, equipment qualifications, equipment operation, and analytical test methods.
• Independently participate in technology transfer, method qualification, and validation.
• Coordinate testing with external contract laboratories, including sample shipment, method transfers, data review, and compliance with company standards and regulatory requirements.
• Support installation, operation, and qualification (IQ/OQ/PQ) of new equipment by drafting or reviewing protocols, executing tests, and coordinating with contract vendors.
• Ensure laboratory equipment is calibrated, maintained, and ready for use; troubleshoot instrumentation as needed.
• Maintain laboratory inventory and supplies and perform routine laboratory housekeeping.
• Lead and conduct routine out-of-specification (OOS) and deviation investigations and implement CAPAs as needed.
• Serve as the primary point of contact for routine testing status in manufacturing and project updates.
• Train manufacturing operators on assay sample preparation and basic equipment handling.
• Analyze, organize, and present data results in weekly meetings.
• Perform other duties as required.

Benefits

• Eligible employees may participate in medical, dental, vision, and prescription coverage.
• Employee wellness resources.
• Savings plans, including a 401(k) and employee stock purchase plan (ESPP).
• Paid time off.
• Paid parental leave benefits.
• Disability benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior